Oral formulations for enteric disorders and/or rehydration

Abstract

The present invention relates, generally, to oral formulations including one or more recombinantly-produced human milk proteins. The formulations of the present invention may be used to prevent the onset of diarrhea in patients who have been or will be exposed to one or more agents known to cause diarrhea, and to prevent the recurrence of diarrhea in a patient recovering therefrom. The formulations may also be used in the treatment of inflammatory bowel disease, including Crohn's disease and ulcerative colitis. The formulations may also be beneficially administered in accordance with methods for promoting the development of healthy intestinal flora in a human patient.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]The present invention relates to the production and use of antimicrobials as components of an oral formulation for preventing and treating enteric disorders caused by a microbial organism or via other sources. The oral formulation may be used for the treatment and / or prevention of various intestinal diseases and conditions, for the control of intestinal pathogens, and for the rehydration of individuals with diarrhea.[0003]2. Background of the Invention[0004]Morbidity and mortality of children under the age of five due to diarrheal diseases remain a major health challenge in developing nations, as well as in lower socioeconomic groups in the developed world. It was not until the 1950s that diarrheal diseases were identified as a major cause of morbidity and mortality in children less than five years of age. The World Health Organization (WHO) reported approximately 1.5 million children under the age of five died from dia...

AI Technical Summary

Benefits of technology

[0036]A further aspect of the invention is an oral formulation including rhLF in an amount from about 0.5 to about 5.0 g / L; and rhLZ in an amount from about 0.1 to about 1.0 g / L. Preferably, the oral formulation has an osmolality of from about 200 to about 310 mOsm / L. The oral formulation preferably delivers antimicrobial activity along with rehydration and feeding to provide a major improvement in reducing the duration and / or severity of intestinal diseases or conditions, and enhancing the rate of recovery.

[0037]Another aspect of the invention comprises a method for the production of an oral formulation, the method comprising incorporating antimicrobials into the formulation, wherein the formulation confers at least one of the following benefits: improving rehydration, preventing the onset or recurrence of diarrhea, reducing diarrhea duration and / or volume, controlling intestinal pathogens such as C. difficile, and promoting the growth of beneficial intestinal flora.

Problems solved by technology

Morbidity and mortality of children under the age of five due to diarrheal diseases remain a major health challenge in developing nations, as well as in lower socioeconomic groups in the developed world.

The replacement of the glucose with boiled rice, rice powder, rice flour or syrup was first tested in early 1980 and resulted in a decrease in stool output and diarrhea duration in cholera patients.

Although the rice-based ORS was superior for adults and children with cholera, it was not superior for children with acute non-cholera diarrhea.

In addition, the group concluded that the increased cost of the rice-based material did not justify changing the WHO recommended formulation.

It has also been pointed out that some developing countries do not have a ready supply of glucose.

(1) Bacterial infections. Several types of bacteria, consumed through contaminated food or water, can cause diarrhea. Common culprits include Clostridium, Campylobacter, Salmonella, Shigella, and Escherichia coli.

(2) Viral infections. Many viruses cause diarrhea, including rotavirus, Norwalk virus, cytomegalovirus, herpes simplex virus, and viral hepatitis.

(3) Food intolerances. Some people are unable to digest some component of food, such as lactose, the sugar found in milk.

The risk of community-acquired C. difficile is very low, but the risk of colonization and overt disease (diarrhea to pseudomembranous colitis) increases in direct relationship to the length of a hospital stay and the use of therapy with antibiotics.

Although most patients respond to specific therapy there are issues of drug intolerance and development resistance.

First was the lack of a sensitive and specific test.

The fact that the treatment for a condition brought about by antibiotic use is another antibiotic may result in the recurrence of disease in a continuously hospitalized patient.

Traditional immunomodulatory therapy, including steroids, can have a significant negative effect on growth and development.

There is a current market absence of a source of safe and cost effective bioactive human milk proteins that exhibit this effect.

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